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510(k) Data Aggregation
K Number
K232525Device Name
Yoni.Fit Bladder Support
Manufacturer
Watkins-Conti Products Inc.
Date Cleared
2024-05-17
(270 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
Watkins-Conti Products Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
Device Description
The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.
Each package of the Yoni.Fit® Bladder Support comes with the following:
- 3 reusable Yōni.Fit® Bladder Supports for sizing .
- . Cleaning brush
- Storage case ●
- Instructions for Use ●
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